- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
CHMP Issues Positive Recommendation for Juta Pharma's Pegfilgrastim Biosimilar
Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Juta Pharma’s pegfilgrastim biosimilar, Grasustek.
Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Juta Pharma’s pegfilgrastim biosimilar, Grasustek.
The next step for the biosimilar will be to await the European Commission (EC)’s final decision on whether to grant a marketing approval for the biosimilar. If the EC ultimately approves the product, it will grant the company a centralized marketing authorization that will be valid in all 28 EU member states. Norway, Iceland, and Liechtenstein, members of the European Economic Area, will follow with corresponding decisions based on the EC’s decision.
If authorized, Grasustek will be available as a 6 mg solution for injection for the prophylaxis of neutropenia in adults being treated with cytotoxic chemotherapy.
The pegfilgrastim biosimilar was developed by USV, a Mumbai-based biosimilar developer that submitted the application for the biosimilar in December 2017. USV later acquired Juta Pharma, a German drug maker with extensive experience in generic drug products.
The application for the biosimilar included data from phase 1 and phase 3 studies of the biosimilar; the phase 1 study compared the pharmacokinetics and pharmacodynamics of the biosimilar with the reference Neulasta at both a therapeutic dose and a low dose, and the phase 3 study followed 254 patients with breast cancer who were scheduled to undergo chemotherapy.
USV also disclosed that it had begun planning for US phase 1 development, and held relevant meetings with the FDA. The company also received approval to initiate phase 3 studies in India.
If Grasustek is authorized in the European Union, it will join already authorized pegfilgrastim biosimilars Fulphila, Ziextenzo, Udenyca, Pelmeg, and Pelgraz. Additional EU-marketed biosimilars used in the prophylaxis of febrile neutropenia are those referencing filgrastim, and include Zarzio (also sold as Filgrastim Hexal), Accofil, Grastofil, Nivestim, and Ratiograstim (also sold as Tevagrastim).
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
